摘要
目的探讨在中国肺癌患者中应用阿瑞匹坦减轻高剂量顺铂为主的化疗方案引起的恶心和呕吐的效果。方法纳入预接受高剂量顺铂为主化疗方案的肺癌患者291例,随机分为两组。阿瑞吡坦组139例,化疗第1日予阿瑞吡坦125 mg;第2,3日,予阿瑞吡坦80 mg,口服。标准治疗组152例,予安慰剂口服。两组均接受静脉注射格拉司琼和口服地塞米松。评估两组总完全反应率及在化疗第1日（急性期）和第2~5日（延迟期）的完全反应率,比较两组接受高度或中度致吐化疗方案患者的完全反应率。结果阿瑞吡坦组总完全反应率为69.1%（96/139）,高于标准治疗组[57.2%（87/152）,P=0.035],延迟期亦高于标准治疗组[72.7%（101/139）vs.59.9%（91/152）,P=0.019],急性期组间无显著差异[79.9%（111/139）vs.80.9%（123/152）,P=0.914]。阿瑞吡坦组接受高度或中度致吐化疗方案患者中完全反应率为60%（3/5）,高于标准治疗组[33%（1/3）,P=0.034]。结论阿瑞吡坦治疗可以预防中国肺癌患者接受高剂量顺铂化疗引起的恶心和呕吐,特别是在延迟期效果优于标准治疗。
AIM To determine the antiemetic efficacy of aprepitant in Chinese lung cancer patients treated with high dose cisplatin- based chemotherapy regimen. METHODS A total of 291 lung cancer patients who were treated with high dose cisplatin were included in this study. Patients were randomized to receive aprepitant（as the aprepitant group, n = 139, day 1, aprepitant 125 mg; days 2- 3, aprepitant 80 mg） or placebo（ as the standard therapy group, n = 152）. Both groups received intravenous granisetron and oral dexamethasone. The efficacy of aprepitant was evaluated by assessing the overall rate of prevention of nausea and vomiting after high dose of cisplatin chemotherapy, as well as in patients in acute and delayed phases of chemotherapy. RESULTS The overall complete response rate was 69.1%（ 96/139） in the aprepitant group,which was higher than that in the standard therapy group（57.2%, 87/152, P = 0.035）. While in the delayed phase, the complete response rate in the aprepitant group was also higher than the standard therapy group（72.7%（101/139） vs. 59.9%（91/152）, P = 0.019）. In the acute phase, no significant difference was found in the complete response rate between two groups（ 79.9%（ 111/139） vs. 80.9%（ 123/152）, P = 0.914）.A total of 60%（ 3/5） of the highly/moderately emetogenic chemotherapy patients in the aprepitant group had complete response compared to 33.3%（1/3） in the standard therapy group, and the difference was significant（ P = 0.034）. CONCLUSION Aprepitant therapy is superior to standard therapy in preventing nausea and vomiting for Chinese lung cancer patients undergoing high- dose cisplatin chemotherapy, especially in the delayed phase.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2015年第10期757-763,共7页
Chinese Journal of New Drugs and Clinical Remedies
基金
funded by MSD China
关键词
阿瑞匹坦
顺铂
抗肿瘤联合化疗方案
肺肿瘤
止吐药
aprepitant
cisplatin
antineoplastic combined chemotherapy protocols
lung neoplasms
antiemetics
